Specialist QA
Specialist QA
Posted on :
11-04-2025
Employer Active
1 Vacancy
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Job Description
SUMMARY
Perform one or more of the following duties and responsibilities in support of Clients Quality Assurance program under minimal supervision.
FUNCTIONS
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
EDUCATION/LICENSES
Doctorate degree or Masters degree and 3 years of directly related experience or Bachelors degree and 5 years of directly related experience years of directly related experience
COMPETENCIES/SKILLS
Project management skills.
Strong organizational skills including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution QA QAL validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing presentation database and spreadsheet application skills.
Strong communication (both written and oral) facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Client Values/Leadership Practices.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Perform one or more of the following duties and responsibilities in support of Clients Quality Assurance program under minimal supervision.
FUNCTIONS
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
EDUCATION/LICENSES
Doctorate degree or Masters degree and 3 years of directly related experience or Bachelors degree and 5 years of directly related experience years of directly related experience
COMPETENCIES/SKILLS
Project management skills.
Strong organizational skills including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution QA QAL validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing presentation database and spreadsheet application skills.
Strong communication (both written and oral) facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Client Values/Leadership Practices.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Required Experience:
Unclear Seniority
Employment Type
Full Time
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